The efficacy and harmlessness of newly developed pharmaceuticals is often proven in the framework of a clinical study with as many study participants as possible. Pharmaceuticals are defined as chemical compounds or preparations that develop a therapeutic effect in people and/or animals, or as auxiliary chemicals (e.g., contrast agents) that support or, in many cases, first enable the diagnosis of a disease.
To implement such a study, for example, pharmaceutical producers normally conclude cooperation agreements with a plurality of clinics that have the clinics, among other things, undertake in particular documentation with special diligence. In the clinical study, incidental data are generated and also documented within a single clinic at a plurality of locations, for example, at diagnostic or other medical devices. A summarizing documentation requires a high organizational effort. This problem is multiplied when, as is typical, a plurality of clinics participate in a study. Additionally, study data are for the most part stored in different logical formats. Thus some clinics write study data with word processing programs, others use data processing programs for it, etc.
An Internet-based method to implement a clinical study is specified in German patent document DE 100 22 039, in which study forms are made available worldwide from a central server (study server) to arbitrary locations after an authorization check. This enables the authors of the study to store the determined results directly on the study server. To implement the study, the participating doctor can call up the study protocol on the websites of the study server after authorization. The doctor follows the instructions that he receives via the websites and enters all of the data material that he has obtained in the execution of the study into the data templates provided.
Standards for a patient information system have been developed for medical devices that allow data to be transmitted and stored without information loss in a heterogeneous infrastructure (as is present in a clinic, a medical practice, or a medical laboratory), even when the devices communicating with one another cannot fully understand transmitted information. It suffices that specific information exists in a standardized format for transmission and storage, for example, address information, information about the data type, etc.
An example of such a standard is the DICOM standard (DICOM=Digital Imaging and Communication). DICOM standardizes the structure of the formats and descriptive parameters for radiological images and commands to exchange these images, but also the specification of other data objects such as frame rate, examination series and findings. The specification of different methods for data compression is also established in DICOM. The DICOM standard is differentiated, roughly speaking, into three different areas or blocks. A first set defined general block that is binding for all producers and modalities comprises instructions to order and distribute data. Furthermore, a modality-specific block is defined that is binding for all producers. Found in this block, for example in the case of magnetic resonance imaging, are the parameters (echo time, repetition time, etc.) thereby used. Finally, there are proprietary blocks that each producer can complete for his own purposes.